Status
Conditions
Treatments
Study type
Funder types
Identifiers
About
Primary aim: to demonstrate that stopping antibiotic treatment in patients diagnosed with acute community acquired pneumonia (CAP) based on clinical response has a non-inferior efficacy 15 days after start of treatment, compared to a conventional predetermined duration left to the physician's judgement, in adults treated in the community setting.
Secondary aims: To compare the 2 study arms on:
Full description
Recent studies have suggested that CAP can be successfully treated by short-course antibiotic regimen when clinical improvement is rapidly obtained. Even if clinical response is obtained in 3 days in the majority of cases, it can widely vary among patients, suggesting that "one duration does not fit all". An individualized duration of therapy depending on the patient's response could help to ensure bacterial eradication while avoiding unnecessary antibiotic exposure and thus reduce antibiotic resistance. At present, this strategy has never been tested.
This is a pragmatic open label non-inferiority randomized multicenter trial with two parallel arms comparing antibiotic treatment duration left to the physician's judgement (usually 7 to 14 days), versus interruption of treatment based on the patient's clinical response defined by reaching stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure ≥ 90mmHg, oxygen saturation ≥ 90%) for 24h, after a minimum of 2 days treatment.
Recruitment and follow-up: Outpatients consulting in a private multiprofessional health center, diagnosed as having CAP and in need for antibiotics will be assessed for eligibility. Following information and signing consent, eligible patients will be included in the study. They will receive the prescription (antibiotic type and duration determined by the physician, preferably chosen according to the French guidelines) and a collection of connected devices to monitor their vital signs 2 times a day (morning and evening). Preselected patients will be randomized as soon as they meet the two following criteria: i) they have presented the stability criteria for 24h (3 consecutive vital signs recordings); ii) they have started the antibiotic treatment at least 72 hours before, with a ≥ 80% compliance, and with at least 1 intake in the last 24 hours. Each patient will then receive a telephone call from the coordinating team (or a permanent medical platform at nights, during weekends or public holidays) in order to proceed to the randomization and ensure that everything is well understood by the patient as well as the security and compliance with the strategy.
A follow-up visit with the investigator will be performed at day 15 after the start of antibiotic treatment.
The final evaluation will be performed 30 days following the start of antibiotic treatment by a telephone call from the coordinating team.
Number of subjects necessary: 310 patients.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Patient aged 18 years or more
Has given written informed consent
Affiliated to Health insurance
Is able to take oral treatment
Presenting with suspected CAP defined by the presence of at least 2 of the following diagnostic clinical criteria:
In need for antibiotic treatment targeting respiratory tract, according to the physician in charge
No other site of infection besides respiratory
Exclusion criteria
All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:
Primary purpose
Allocation
Interventional model
Masking
310 participants in 2 patient groups
Loading...
Central trial contact
Aurélien DINH, MD; Anne-Claude CRÉMIEUX, MD, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal